Lung Injury, AcuteNCT06900426
Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction
A study testing 10 PEEP, ZEEP and 5PEEP in people with Lung Injury, Acute, run by Fudan University at 1 site in China.
Trial summary
Anesthetic induction could lead to lung atelectasis, increase intrapulmonary shunt, and potentially impair oxygenation. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Injury, Acute
- What is being tested?
- 10 PEEP, ZEEP and 5PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 80 years
- scheduled for elective non-cardiothoracic cancer surgery
- general anesthesia.
Who cannot join
- acute or chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) or asthma;
- a history of lung surgery
- a high risk of reflux and aspiration
- a requirement for awake intubation
- facial or thoracic deformities
- the presence of implants, such as cardiac pacemakers
- pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction: a Randomized Trial
Anesthetic induction could lead to lung atelectasis, increase intrapulmonary shunt, and potentially impair oxygenation. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension.
Read the detailed description
General anesthesia may introduce lung atelectasis, which causes an increase in intrapulmonary shunt, and impairs oxygenation, even in the lung-healthy subjects. The magnitude of shunt is correlated with the formation of pulmonary atelectasis. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension. Surgical patients with healthy lungs were randomly assigned to receive 0, 5 or 10 cmH2O PEEP (PEEP0, PEEP5 and PEEP10 groups). Anesthetic induction was performed by certified registered anesthesiologists, during which the patients were mechanically ventilated using the volume-controlled mode. Electrical impedance tomography (EIT) was used to dynamically assess the lung atelectasis during anesthetic induction (spontaneous, mask, and endotracheal intubation ventilation). The primary outcome was the dorsal change of end expiratory lung impedance (△EELI) after 2 mins anesthetic induction. The secondary outcome was driving pressure, EIT-derived ventilation homogeneity, hemodynamics and PaO2/FiO2.
- Conditions
- Lung Injury, Acute
- Being tested
- 10 PEEP, ZEEP, 5PEEP
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 PEEPOther
Using 10cmH2O PEEP during anesthetic induction monitored by EIT.
ZEEPOther
No PEEP
5PEEPOther
Using 5cmH2O PEEP
| Study group | Role | What they receive |
|---|---|---|
| PEEP0 | Other | There is ZEEP during anesthetic induction Receives: Other: ZEEP |
| PEEP5 | Experimental | There is 5 cmH2O PEEP during anesthetic induction. Receives: Other: 5PEEP |
| PEEP10 | Experimental | There is 10 cmH2O PEEP during anesthetic induction. Receives: Other: 10 PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the dorsal △EELV after 2 minutes anesthetic induction
The primary outcome was the dorsal △EELV after 2 minutes anesthetic induction (endotracheal intubation ventilation) monitored by EIT.
Measured: 2 minutes after anesthetic induction
Secondary outcomes (5)
driving pressure
Pplat - PEEP
Measured: 2 minutes after anesthetic induction
GI
Global imhomogeneity monitored by EIT
Measured: 2 minutes after anesthetic induction
CoV
The central of ventilation monitored by EIT
Measured: 2 minutes after anesthetic induction
hemodynamics
Blood pressure
Measured: During anesthetic induction
PaO2/FiO2
PaO2/FiO2 during anesthetic induction
Measured: During anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start28 Mar 2025
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, Professor, Principal investigator, Fudan University Shanghai Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900426
- Sponsor's protocol ID
- 2502-Exp148
- Status last verified
- May 2025
- First submitted
- 17 Mar 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets are available from the corresponding author on reasonable request.
Publications
Yang L, Wu L, Ye J, Zhao Z, Zhang J. Applying positive end-expiratory pressure to facemask ventilation improves post-induction lung atelectasis: a three-arm randomized controlled trial. BMC Anesthesiol. 2025 Oct 17;25(1):509. doi: 10.1186/s12871-025-03352-z.
PubMed 41107724
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Atelectasis Improvement Through Positive End Expiratory Pressure During Anesthetic Induction: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06900426
- Acronym / sponsor ID
- 2502-Exp148
- Conditions
- Lung Injury, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anesthetic induction could lead to lung atelectasis, increase intrapulmonary shunt, and potentially impair oxygenation. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension.
Detailed description
General anesthesia may introduce lung atelectasis, which causes an increase in intrapulmonary shunt, and impairs oxygenation, even in the lung-healthy subjects. The magnitude of shunt is correlated with the formation of pulmonary atelectasis. The study aimed to validate that a positive end-expiratory pressure (PEEP) of 10 cmH2O could reduce lung atelectasis, comparing to 0 or 5 cmH2O with limited overdistension. Surgical patients with healthy lungs were randomly assigned to receive 0, 5 or 10 cmH2O PEEP (PEEP0, PEEP5 and PEEP10 groups). Anesthetic induction was performed by certified registered anesthesiologists, during which the patients were mechanically ventilated using the volume-controlled mode. Electrical impedance tomography (EIT) was used to dynamically assess the lung atelectasis during anesthetic induction (spontaneous, mask, and endotracheal intubation ventilation). The primary outcome was the dorsal change of end expiratory lung impedance (△EELI) after 2 mins anesthetic induction. The secondary outcome was driving pressure, EIT-derived ventilation homogeneity, hemodynamics and PaO2/FiO2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP0 | Other | Other: ZEEPThere is ZEEP during anesthetic induction |
| PEEP5 | Experimental | Other: 5PEEPThere is 5 cmH2O PEEP during anesthetic induction. |
| PEEP10 | Experimental | Other: 10 PEEPThere is 10 cmH2O PEEP during anesthetic induction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 80 years
- scheduled for elective non-cardiothoracic cancer surgery
- general anesthesia.
Key exclusion criteria (7 listed)
- acute or chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) or asthma;
- a history of lung surgery
- a high risk of reflux and aspiration
- a requirement for awake intubation
- facial or thoracic deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 PEEPUsing 10cmH2O PEEP during anesthetic induction monitored by EIT. | Other | PEEP10 |
| ZEEPNo PEEP | Other | PEEP0 |
| 5PEEPUsing 5cmH2O PEEP | Other | PEEP5 |
Primary outcome
the dorsal △EELV after 2 minutes anesthetic induction
Time frame: 2 minutes after anesthetic induction
The primary outcome was the dorsal △EELV after 2 minutes anesthetic induction (endotracheal intubation ventilation) monitored by EIT.
5 secondary outcomes
driving pressure
Time frame: 2 minutes after anesthetic induction
GI
Time frame: 2 minutes after anesthetic induction
CoV
Time frame: 2 minutes after anesthetic induction
hemodynamics
Time frame: During anesthetic induction
PaO2/FiO2
Time frame: During anesthetic induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Derived from this study: PubMed 41107724Yang L, Wu L, Ye J, Zhao Z, Zhang J. Applying positive end-expiratory pressure to facemask ventilation improves post-induction lung atelectasis: a three-arm randomized controlled trial. BMC Anesthesiol. 2025 Oct 17;25(1):509. doi: 10.1186/s12871-025-03352-z.
- Individual participant dataSharing planned: Yes. The data sets are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, Professor principal investigator
Fudan University Shanghai Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 PEEP, ZEEP and 5PEEP in people with Lung Injury, Acute, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the dorsal △EELV after 2 minutes anesthetic induction (time frame: 2 minutes after anesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.